Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Geron Corporation
Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed adenocarcinoma of the breast that is either locally recurrent or metastatic. Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent
Either have not received chemotherapy or may have had one prior non-taxane chemotherapy regimen for metastatic disease (there are no restrictions on prior hormonal therapy)
Prior use of bevacizumab is allowed provided that it was not administered in combination with a taxane
ECOG performance status 0-1
Adequate bone marrow reserve as indicated by:
* ANC \> 1500/uL (without use of growth factors within 7 days)
Locally recurrent disease amenable to resection with curative intent
HER-2-positive breast cancer
Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
Investigational therapy within 4 weeks of first study drug administration
Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
Grade ≥ 2 neuropathy
Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
Severe conduction disturbance including clinically significant QTC prolongation \> 450 ms (unless pacemaker in place)
Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
Clinically relevant active infection
Known positive serology for human immunodeficiency virus (HIV)
Clareo Health | Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer
